New study aims to boost IUI success with a simple, fixed hormone dose
NCT ID NCT07153367
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial is testing whether a fixed dose of the hormone follitropin delta (Rekovelle) can improve ovarian stimulation for intrauterine insemination (IUI) in women with regular cycles. The goal is to promote the growth of two mature eggs per cycle to increase pregnancy chances while minimizing the risk of multiple pregnancies. Eighty participants aged 18-38 will receive the same dose and be monitored closely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- follitropin delta (Rekovelle)
- What this could lead to
- If successful, this could offer a simpler, more effective starting dose for ovarian stimulation in intrauterine insemination, potentially increasing pregnancy rates while lowering the risk of multiple births.
- What could go wrong
- This is a small Phase 2 trial with only 80 participants, so results may not apply to all patients. The fixed dose may not work for everyone, and there is still a risk of ovarian hyperstimulation or multiple pregnancy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 38 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Normo-ovulatory patients * 18 - 38 included years old * BMI between 18 and 29 included kg/m² * Regular menstrual cycles * At least one healthy Fallopian tube * Normal uterus cavity * First treatment for IUI * Affiliation to the social security Exclusion Criteria: * Endometriosis Stage III * Total mobile sperm count \<1 million * Severe spermatogenesis disorders * Women with Poly Cystic Ovary Syndrom * History of OHSS or excessive response to gonadotrophins * Chronic disease with contraindication to ovarian stimulation with gonadotrophins * Known genetic disease * Hypothalamus or pituitary tumors * Ovarian hypertrophy or ovarian cyst not due to polycystic ovary syndrome * Gynecological bleeding of unknown etiology * Ovarian, uterine or breast carcinoma * Primary ovarian failure * Genital malformations incompatible with pregnancy * Uterine fibroids incompatible with pregnancy * Protected persons (pregnant women, nursing mothers, person under guardianship, minors, persons deprived of liberty, and persons unable to give consent) * Tumors (including meningioma) whose development is known or suspected to be progesterone-dependent * History of hepatic dysfunction * Have been receiving progestogen therapy for more than 6 months * Known contraindication to hormonal treatments (progestogens or oestrogens), or with a history of adverse events related to their use * Previous thromboembolism events during or following the use of gonadotrophins or with high risk factors for thromboembolic events (venous or arterial) * Previous or current treatment with gonadotrophins * Hypersensitivity to the active substance or to any of the excipients * High risk of OHSS such as women with AMH ≥ 35 pmol/L * History of severe uterine malformation (unicornuate or bicornuate uterus), * Past history of ovarian torsion * Uncontrolled thyroid dysfunction * Uncontrolled adrenal dysfunction * Hydrosalpynx * Breast pathologies not compatible with gonadotrophin stimulation * Use of infertility medications that could affect follicle stimulation and maturation such as GH * Participation in other interventional research * Not able to understand and sign the written informed consent form
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cabinet Dr Elodie Descat-Polyclinique Jean Villar
RECRUITINGBruges, 33520, France
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Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction
RECRUITINGMarseille, 13008, France
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Cabinet Dr Nathalie Massin- Hôpital Américain De Paris
SUSPENDEDNeuilly-sur-Seine, 92200, France
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Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch
RECRUITINGMontpellier, 34070, France
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Chi Creteil
RECRUITINGCréteil, 94000, France
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